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- Aufgaben: Lead quality management and regulatory interactions across Europe and beyond.
- Arbeitgeber: Join a dynamic team focused on medical device compliance and quality assurance.
- Mitarbeitervorteile: Enjoy flexible work options and opportunities for professional growth.
- Warum dieser Job: Make an impact in healthcare by ensuring product safety and compliance.
- Gewünschte Qualifikationen: 4+ years in quality management; degree in engineering or biomedical field required.
- Andere Informationen: Fluency in English and B2 German is essential; coaching skills are a plus.
Das voraussichtliche Gehalt liegt zwischen 54000 - 84000 € pro Jahr.
We are looking for a highly skilled individual to assist the quality management and touchpoints with regulatory bodies across various business units or subsidiary companies with a specific focus on Europe and other regions.
Responsibilities
- Establish and maintain Quality System requirements effectively.
- Collaborate with junior peers to set and achieve quality and regulatory goals.
- Assist in preparations and negotiations with regulatory agencies for new markets and act as a contact for existing markets.
- Ensure business teams consider the impact of current or emerging quality and regulatory issues.
- Provide regulatory training and mentoring to staff across various departments.
- Explain audit findings, resolve conflicts, and consult on corrective and preventative actions.
- Interface with Regulatory Agencies during inspections.
- Represent the organization during regulatory and client inspections/audits.
- Prepare site/operation personnel for regulatory audits and create summaries and reports of such audits.
- Track corrective actions and update management on their status.
- Perform general auditing duties to ensure compliance with quality standards.
- Assist in the final review and management of SOPs and QM-related documents.
- Assist with Vendor Assessment, client audits, and subcontractor audits.
- Manage Technical Documentation for submissions and product changes.
- Optimize Quality and Regulatory processes and ensure global QA RA compliance.
Requirements:
- Degree in engineering, biomedical, or a related field; a Master\’s degree or MBA is a plus.
- 4+ years of experience in quality management and regulatory affairs for medical devices.
- Proven experience handling submissions, technical documentation, and the approval process (MDD / MDR / De Novo or 510(k)).
- Specialist knowledge of medical device QMS (ISO 13485 / 21 CFR 820).
- Experience managing external audits with notified bodies and competent authorities.
- Experience in risk management of medical devices as per ISO 14971 and implementing various medical device standards.
- Knowledge of standards for electrical testing, EMC testing (ISO 60601), or ISO 62366 series, and conducting Post Market Surveillance activities is advantageous.
- Coaching and mentoring skills.
- Fluency in English and B2 level of German.
- Flexible, goal-oriented, and a team player.
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Senior QA/RA Manager Arbeitgeber: EPM Scientific - Phaidon International
Kontaktperson:
EPM Scientific - Phaidon International HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Senior QA/RA Manager
✨Tip Number 1
Make sure to network with professionals in the medical device industry, especially those who have experience in quality management and regulatory affairs. Attend relevant conferences or webinars where you can meet potential colleagues and learn about the latest trends in QA/RA.
✨Tip Number 2
Familiarize yourself with the specific regulations and standards that apply to the regions you will be working in, particularly in Europe. Understanding the nuances of MDD, MDR, and ISO standards will give you an edge during interviews and discussions.
✨Tip Number 3
Prepare to discuss your past experiences with regulatory submissions and audits in detail. Be ready to share specific examples of how you've successfully navigated challenges in quality management and regulatory compliance.
✨Tip Number 4
Highlight your coaching and mentoring skills during conversations. Being able to demonstrate how you've helped junior peers or teams achieve their quality and regulatory goals will show that you're a strong leader and team player.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Senior QA/RA Manager
Tipps für deine Bewerbung 🫡
Tailor Your CV: Make sure your CV highlights your experience in quality management and regulatory affairs, especially in the medical device sector. Emphasize your familiarity with ISO standards and any relevant certifications.
Craft a Strong Cover Letter: In your cover letter, clearly articulate your motivation for applying to this position. Discuss how your background aligns with the responsibilities listed, particularly your experience with regulatory agencies and quality systems.
Showcase Relevant Experience: When detailing your work history, focus on specific projects or roles where you managed submissions, audits, or compliance with quality standards. Use metrics or outcomes to demonstrate your impact.
Prepare for Potential Questions: Anticipate questions related to your experience with regulatory bodies and quality management systems. Be ready to discuss specific challenges you've faced and how you resolved them, as well as your approach to mentoring and training others.
Wie du dich auf ein Vorstellungsgespräch bei EPM Scientific - Phaidon International vorbereitest
✨Showcase Your Regulatory Knowledge
Be prepared to discuss your experience with regulatory submissions and approvals, especially related to MDD, MDR, and 510(k). Highlight specific examples where you successfully navigated complex regulatory environments.
✨Demonstrate Quality Management Expertise
Discuss your familiarity with quality management systems, particularly ISO 13485 and 21 CFR 820. Provide insights into how you've established or maintained quality systems in previous roles.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world situations. Prepare to explain how you would handle audit findings or conflicts with regulatory agencies, showcasing your conflict resolution abilities.
✨Emphasize Team Collaboration
Since the role involves collaboration with junior peers and various departments, be ready to share examples of how you've successfully mentored others and worked as part of a team to achieve quality and regulatory goals.
